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Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrin...

FDA Drug Recall #D-1254-2014 — Class III — April 14, 2014

Recall Summary

Recall Number D-1254-2014
Classification Class III — Low risk
Date Initiated April 14, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm P&L Developments, LLC
Location Lynwood, CA
Product Type Drugs
Quantity 2,500,510 bottles

Product Description

Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170

Reason for Recall

Subpotent Drug: Phenylephrine component is subpotent.

Distribution Pattern

Nationwide in US

Lot / Code Information

Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).

Other Recalls from P&L Developments, LLC

Recall # Classification Product Date
D-1298-2014 Class III Children's Triacting Night Time Cold & Cough wi... Apr 15, 2014

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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